Using community engagement with FRAME: Framework for reporting adaptations and modifications to evidence-based interventions.

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Contemporary Clinical Trials Communications Pub Date : 2024-11-26 eCollection Date: 2024-12-01 DOI:10.1016/j.conctc.2024.101398
Jordana L Clayton, Rebecca L Utz, Nancy Aruscavage, Sara G Bybee, Sharon E Bigger, Eli Iacob, Kara B Dassel
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引用次数: 0

Abstract

Community engagement is increasingly considered a key component of intervention development, as it can leverage community members' knowledge, experiences, and insights to create a nuanced intervention which meets the needs, preferences, and realities of the population of interest. Community engagement exists along a spectrum from outreach to the community to partnership with community members and organizations, and all levels of community engagement can benefit from systematic documentation of community feedback and decision-making processes. This paper demonstrates how we utilized the "Framework for Reporting Adaptations and Modifications to Evidence-based Interventions" (FRAME; Wiltsey Stirman et al., 2019) model to track and report adaptations to our dementia end-of-life care planning intervention based on community engagement via a project-specific Community Advisory Board (CAB). Using FRAME, we generated a comprehensive report of the iterative changes made to our pilot intervention, including whether the change was planned, who made the decision to modify the intervention, the nature of the change, its relationship to intervention fidelity, and the reason for the change. This process ensured that we effectively integrated feedback and assistance from our CAB, increased the appropriateness of our intervention for our population of interest, established criteria to monitor intervention fidelity, and prepared our team to run a rigorous clinical trial of the revised intervention. Clinical Trial Registration Number: NCT05909189.

利用社区参与FRAME:报告基于证据的干预措施的适应和修改的框架。
社区参与越来越被认为是干预措施开发的关键组成部分,因为它可以利用社区成员的知识、经验和见解来创建一个细致入微的干预措施,以满足感兴趣人群的需求、偏好和现实。社区参与存在于从社区外展到与社区成员和组织合作的各个层面,所有层次的社区参与都可以从社区反馈和决策过程的系统文档中受益。本文展示了我们如何利用“基于证据的干预措施适应和修改报告框架”(FRAME;Wiltsey Stirman等人,2019)通过特定项目的社区咨询委员会(CAB)跟踪和报告基于社区参与的痴呆症临终关怀计划干预的适应情况。使用FRAME,我们生成了对我们的试验干预所做的迭代变更的综合报告,包括变更是否被计划,谁做出了修改干预的决定,变更的性质,它与干预保真度的关系,以及变更的原因。这个过程确保了我们有效地整合了来自CAB的反馈和帮助,增加了我们的干预对我们感兴趣的人群的适当性,建立了监测干预保真度的标准,并为我们的团队做好了对修订后的干预进行严格临床试验的准备。临床试验注册号:NCT05909189。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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